Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences

Purpose

The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.

Conditions

  • Naltrexone
  • Placebo

Eligibility

Eligible Ages
Between 18 Years and 25 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • good health - English fluency - willing to provide contact information for 4-6 close others - willing to provide digital photographs of 2 close others - own a smartphone

Exclusion Criteria

  • presence of medical devices, implants, or other metal objects in or on the body that cannot be removed - tattooed eyeliner - a body habitus prohibiting MRI scanning - claustrophobia - self-reported chronic mental or physical illness - current and regular use of prescription medication - previous history of having difficulty taking pills - current use of opioid analgesics - depressive symptoms above a 9 on Patient Health Questionnaire - excessive alcohol use - positive urine drug test - body mass index (BMI) greater than 35 - pregnancy or plans to become pregnant in next 6 months - positive urine pregnancy test

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Naltrexone 		50mg naltrexone HCL once daily for seven days by mouth
  • Drug: Naltrexone Hydrochloride
    oral naltrexone
    Other names:
    • oral naltrexone
    • naltrexone pill
    • naltrexone
    • naltrexone oral tablet
Placebo Comparator
placebo 		sugar pill once daily for seven days by mouth
  • Drug: Placebo
    oral sugar pill
    Other names:
    • sugar pill

Recruiting Locations

San Diego State University
San Diego 5391811, California 5332921 92120
Contact:
Tristen Inagaki, PhD

More Details

Status
Recruiting
Sponsor
San Diego State University

Study Contact

Tristen Inagaki, PhD
6195941058
tinagaki@sdsu.edu